Ondansetron 4mg Film Coated Tablets
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(Ondansetron)
Read all of this leaflet carefully before this medicine is administered to you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ondansetron Tablets are and what they are used for
2. Before Ondansetron Tablets are taken
3. How to take Ondansetron Tablets
4. Possible side effects
5. How to store Ondansetron Tablets
6. Further information
The name of your medicine is Ondansetron 4 mg Film-Coated Tablets and 8 mg Film-Coated Tablets (also referred to as Ondansetron Tablets throughout this leaflet).
1. WHAT ONDANSETRON TABLETS ARE AND WHAT THEY ARE USED FOR
Ondansetron belongs to the group of medicines known as antiemetics.
Ondansetron is used to treat nausea and vomiting caused by cancer chemotherapy or radiotherapy (in adults and children). It is also used to prevent and treat sickness that can sometimes occur after an operation (adults only).
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed but bought/obtained without a prescription. In particular you should tell your doctor if you are taking any of the following:
• phenytoin, used in the treatment of epilepsy
• carbamazepine, used to treat epilepsy and bipolar disorder
• rifampicin, an antibiotic used to treat bacterial infections.
Ondansetron may reduce the effects of tramadol.
The use of ondansetron with medicines that affect the heart (e.g. anthracyclines such as doxorubicin and idarubicin) may increase the risk of arrhythmias (changes in your heart beat).
In patients receiving cancer chemotherapy with medicines such as doxorubicin, the rhythm of the heart may be affected.
In patients who are being treated with medication that suppresses abnormal rhythms of the heart.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding you should talk to your doctor or pharmacist before taking any medicine.
Driving vehicles and using machines
Ondansetron does not affect your ability to drive or operate machines.
Important information about some of the ingredients of Ondansetron Tablets
This medicinal product contains lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking Ondansetron Tablets.
2. BEFORE YOU TAKE ONDANSTERON TABLETS
3. HOW TO TAKE ONDANSETRON TABLETS
Do not take Ondansetron Tablets if any of the
following apply to you.
• you are allergic (hypersensitive) to ondansetron or any of the other ingredients of Ondansetron Tablets (please refer to Section 6 for full list of ingredients).
An allergic reaction may include rash, itching, swelling of face, lips, tongue or hands/feet, or breathing difficulties.
Take special care with Ondansetron Tablets
• if you have symptoms of subacute intestinal obstruction (blockage in the bowel) such as stomach ache, nausea, vomiting or difficulty in passing wind
• if you have undergone tonsil surgery. Prevention of nausea and vomiting with ondansetron may mask hidden bleeding. Therefore, such patients should be monitored carefully after taking Ondansetron
• if you are having cancer chemotherapy, especially if you are a child, you will be monitored more closely.
• if you have an abnormal heart rhythm, suffer from palpitations, take drugs to control your heart rhythm, take beta-blocking drugs or if you have significant abnormalities of the electrolytes (sodium and potassium salts) in your blood.
Please consult your doctor, even if these statements
were applicable to you at any time in the past.
Adults over 18 years of age
For oral use.
Always take Ondansetron Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Unless told otherwise, take the tablets with water.
To obtain a tablet press on the tablet from the blister (or bubble) side, pushing it through the foil. Do not remove the tablet from the blister until you are ready to take it.
For most patients receiving chemotherapy or radiotherapy that causes nausea and vomiting: the
recommended dose is 8 mg, given by injection, two hours before chemotheraphy, followed by 8 mg, given orally, after 12 hours.
For patients receiving chemotherapy that causes severe nausea and vomiting: any of the following dose schedules are recommended:
• 8 mg by injection, immediately before chemotherapy
• 8 mg by injection, immediately before chemotherapy followed by two further doses of 8 mg, given by injection 2 to 4 hours apart.
You may be told to take Ondansetron Tablets every 12 hours for up to 5 days to prevent any further nausea and vomiting.
Children over 6 months and adolescents
The doctor will decide the dose. Look at the label for more information.
• the usual dose for a child is up to 8mg given by injection, immediately before chemotherapy.
• this can be followed by further oral doses up to 4mg every 12 hours given for up to five days. The total daily dose must not exceed 32mg.
To prevent nausea and vomiting after an operation: the usual adult dose is a single dose of 4mg, given by injection before the operation.
Children aged over 1 month and adolescents
It is recommended that ondansetron is given as an injection.
Patients with moderate or severe liver disease: the
total daily dose should not be more than 8 mg.
If you take more Ondansetron Tablets than you should
If you or anybody else takes too many tablets, you should contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any tablets you have left to show the doctor or pharmacist.
If you forget to take Ondansetron Tablets
If you forget to take a dose and are feeling sick or being sick, take the dose as soon as possible. If you miss a dose but are not feeling sick or being sick, just take the next dose when it is due. Never double the next dose to make up for the one missed.
If you stop taking Ondansetron Tablets
Do not stop taking the medicine without talking to your doctor first.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ondansetron can have side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
A few people can be allergic to some medicines; if any of the following rare side effects come on soon after taking your tablets tell your doctor immediately:
• sudden chest tightness or wheezing
• swelling of eyelids, face or lips
• skin rashes - red spots or hives (skin lumps)
• collapse.
The following side effects are uncommon or very rare but if you have them you should let your doctor know immediately:
• upward rolling of the eyes
• abnormal muscular stiffness, body movements or shaking
• fits
• blurring of vision
• temporary blindness
• yellowing of the skin or whites of the eyes caused by liver problems
• low blood pressure (symptoms may include dizziness, fainting and nausea).
• slow or irregular heartbeat
• chest pain
Other possible side effects are:
• headache
• feeling of warmth in the head or stomach
• flushes of the face
• hiccups
• upset bowels - constipation.
• nausea
• vomiting
If you have any blood tests to check how your liver is working, this medicine may affect the results. If you feel unwell or have any other unusual discomfort you do not understand, tell your doctor as soon as possible.
5. HOWTO STORE ONDANSETRON TABLETS
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Ondansetron Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not take Ondansetron Tablets if you notice they are discoloured (they should be pale yellow).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Ondansetron Tablets contain
• the active substance is Ondansetron (as Ondansetron hydrochloride dihydrate)
• each tablet contains either 4mg or 8mg Ondansetron (as Ondansetron hydrochloride dihydrate)
• the other ingredients are lactose monohydrate, microcrystalline cellulose (E460(i)), pregelatinised starch, magnesium stearate, hypromellose (E464), titanium dioxide (E171), hyprolose, propylene glycol (E1520), sorbitan oleate (E494), sorbic acid (E200), vanillin and quinoline yellow (E104).
What Ondansetron Tablets look like and contents of the pack
Ondansetron 4mg Film-Coated Tablets are pale yellow, round, biconvex, film-coated tablets with '4T embossed on one side. Ondansetron 8mg Film-Coated Tablets are pale yellow, round, biconvex, film-coated tablets with '42’ embossed on one side.
Ondansetron 4mg tablets are available in blister packs of 30 tablets and Ondansetron 8mg tablets are available in blister packs of 10 tablets.
Marketing Authorisation Holder
Wockhardt UK Limited, Ash Road North, Wrexham,
LL13 9UF, United Kingdom.
Manufacturer
CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, United Kingdom. Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following information:
|
Product name |
Reference number |
|
Ondansetron 4 mg Tablets |
29831/0155 |
|
Ondansetron 8 mg Tablets |
29831/0156 |
This is a service provided by the Royal National Institute of Blind People.
This leaflet was revised in March 2012. 103229/4